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What is XELJANZ?

XELJANZ (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

  • Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

It is not known if XELJANZ is safe and effective in children or in people with Hepatitis B or C.

XELJANZ is not recommended for people with severe liver problems.

Questions: 
What should I do if my pharmacy does not accept the Co-Pay Savings Card?
Body: 

If you are eligible for the Co-Pay Savings Card, but your pharmacy does not accept it, a rebate form is available to reimburse you for the co-pay amount. Instructions on how to redeem are included on the form. Terms and conditions/eligibility requirements apply.

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Contact Us

If you have questions, concerns or comments, please call our XELJANZ Information Center toll-free at 1-844-935-5269 Monday through Friday, 8:00 AM–8:00 PM ET.

Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088. By clicking on this link, you will be leaving UC.XELJANZ.com. This website is neither owned nor controlled by Pfizer. Pfizer does not endorse and is not responsible for the content and services of this site.

 

CO-PAY CARD TERMS AND CONDITIONS

By using the XELJANZ/XELJANZ XR Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.

  • Patients are not eligible to use this card if they are enrolled in a state- or federally-funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
  • This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs.
  • You will receive a maximum benefit of $15,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year, and may pay as little as $0 per month co-pay. After a maximum of $15,000, you will be responsible for paying the remaining monthly out-of-pocket costs.
  • The Card may be used once per month for the life of the program.
  • You must deduct the value of this coupon from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
  • Cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription.
  • The Card will be accepted only at participating pharmacies.
  • The Card is not health insurance.
  • The Card is not available to cash paying customers.
  • The Card is not valid where prohibited by law.
  • Offer good only in the US and Puerto Rico.
  • The Card is limited to 1 per person during this offering period and is not transferable.
  • Pfizer reserves the right to rescind, revoke, or amend the program without notice.
  • Data related to your redemption of the Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Card redemptions and will not identify you.
  • No membership fee.
  • Card and Program expires 12/31/2019.

If you have questions or are in need of additional support, call 1-844-XELJANZ (1-844-935-5269) or visit www.XELJANZ.com.

Important Safety Information & Indications

 

IMPORTANT SAFETY INFORMATION

XELJANZ may cause serious side effects, including:

Serious infections. XELJANZ can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

Your healthcare provider should test you for TB before starting and during XELJANZ treatment, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of serious infections and shingles.

Before starting XELJANZ, tell your healthcare provider if you:

think you have an infection or have symptoms of an infection, such as fever, sweating, or chills; cough; blood in phlegm; warm, red, or painful skin or sores on your body; burning when you urinate or urinating more often than normal; muscle aches; shortness of breath; weight loss; diarrhea or stomach pain; or feeling very tired

are being treated for an infection

get a lot of infections or have infections that keep coming back

have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections

have TB, or have been in close contact with someone with TB

live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use XELJANZ. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common

have or have had Hepatitis B or C

After starting XELJANZ, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ can make you more likely to get infections or make worse any infection that you have.

Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

Cancer and immune system problems. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ. People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.

Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT)  and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR.  The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day. Blood clots in the lungs have also happened in patients with ulcerative colitis.  Some people have died from these blood clots.

Stop taking XELJANZ/ XELJANZ XR and tell your healthcare provider right away if you have any signs and symptoms of a blood clot such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.

Serious allergic reactions have happened in patients taking XELJANZ. If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ and call your healthcare provider right away.

Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ, and while you take XELJANZ, to check for the following side effects:

Changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.

Low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.

Low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.

Your healthcare provider should routinely check certain liver tests.

You should not receive XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ treatment for a period of time if needed because of changes in these blood test results.

You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start XELJANZ, and as needed after that.

What should I tell my healthcare provider before taking XELJANZ?

Before taking XELJANZ, tell your healthcare provider about all of your medical conditions, including if you:

have an infection

have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past.

have liver problems

have kidney problems

have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines

have had a reaction to tofacitinib or any of the ingredients in XELJANZ

have recently received or are scheduled to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines

plan to become pregnant or are pregnant. XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.

Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll

plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ, do not start breastfeeding again until 18 hours after your last dose of XELJANZ.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about any other medicines you take to treat your ulcerative colitis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), golimumab (Simponi®), ustekinumab (Stelara®), secukinumab (Cosentyx®), vedolizumab (Entyvio®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ. Taking XELJANZ with these medicines may increase your risk of infection.

Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Taking XELJANZ

Take XELJANZ 2 times a day with or without food.

Do not take XELJANZ XR for ulcerative colitis.

What are other possible side effects of XELJANZ? XELJANZ may cause serious side effects, including Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before you start treatment with XELJANZ and while you are using XELJANZ. Tell your healthcare provider if you have any of the following symptoms of a possible Hepatitis B or C infection: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

Common side effects of XELJANZ in ulcerative colitis patients include nasal congestion, sore throat, and runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

What is XELJANZ? XELJANZ (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

It is not known if XELJANZ is safe and effective in children or in people with Hepatitis B or C.

XELJANZ is not recommended for people with severe liver problems.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

 

XELSOURCE & XELJANZ ACCESS
TERMS & CONDITIONS

PFIZER PATIENT ASSISTANCE PROGRAM ELIGIBILITY CRITERIA

  • The Pfizer Patient Assistance Program is not health insurance and is available for eligible uninsured/underinsured patients only.
  • Offer is only available to patients who meet financial and other criteria.
  • This offer does not require, nor will it be made contingent on, purchase requirements of any kind.
  • No claim for reimbursement or credit for any costs associated with the medicine(s) may be submitted to any prescription insurance provider or payer, including Medicare Part D plans.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Offer good only in the US and Puerto Rico.
  • Patient must be a resident of the US or Puerto Rico.
  • Prescription must be provided by a healthcare provider licensed in the US or Puerto Rico.
  • Patient must be treated in the outpatient setting of care.
  • Additional eligibility criteria may apply. Contact XELSOURCE for details.

INTERIM CARE Rx PROGRAM TERMS & CONDITIONS

  • Interim Care Rx is not health insurance and is available for eligible, commercially insured patients only.
  • Offer is only available to patients who have been diagnosed with an FDA-approved indication for XELJANZ/XELJANZ XR.
  • No claim for reimbursement for product dispensed pursuant to this offer may be submitted to any third-party payer.
  • Not available to patients covered under government plans such as Medicaid, Medicare or other federal or state healthcare programs, including any state prescription drug assistance programs and the Government Health Insurance Plan or for residents of Massachusetts, Michigan, Minnesota, Missouri, Ohio, or Rhode Island.
  • Available in 30-day supply. Refills are subject to limitations.
  • Interim Care Rx offer does not require, nor will be made contingent on, purchase requirements of any kind.
  • Pfizer reserves the right to amend, rescind, or discontinue this program at any time without notification.
  • Interim Care Rx can only be dispensed by the exclusive pharmacy and only after benefits investigation has been completed and a delay occurs in the prior authorization or appeals process.
  • Offer good only in the US and Puerto Rico.
  • Prescription must be provided by a healthcare provider licensed in the US or Puerto Rico.
  • Additional eligibility criteria may apply. Contact XELSOURCE for details.

VOUCHER TERMS AND CONDITIONS

By redeeming this voucher, you acknowledge that you currently meet the eligibility criteria and will comply with the terms & conditions described below:

  • You will receive a one-time, 30-day supply of XELJANZ.
  • Only new patients may use this voucher. By redeeming this voucher, you certify that you are not currently using XELJANZ.
  • An original voucher and a valid prescription must be presented to the pharmacy.
  • The voucher will be accepted only at participating pharmacies.*
  • You must not submit any claim for reimbursement for product dispensed pursuant to this voucher to any third-party payor, including Medicare, Medicaid, or any other federal or state health care program. You cannot apply the value of the free product received through this voucher toward any government insurance benefit out-of-pocket spending calculations, such as Medicare Part D True Out-of-Pocket Costs (TrOOP).
  • You must be 18 years of age or older to redeem this voucher.
  • This voucher is not valid where prohibited by law.
  • This voucher cannot be combined with any other savings, free trial or similar offer for the specified prescription. This voucher should not be combined with samples for the specified prescription.
  • This free trial voucher is not health insurance. This free trial voucher is not intended to address delays or gaps in health insurance coverage for the specified prescription.
  • Offer good only in the U.S. and Puerto Rico.
  • No purchase is necessary.
  • Patients have no obligation to continue to use XELJANZ. 
  • Pfizer reserves the right to rescind, revoke, or amend this offer without notice.
  • This voucher expires 12/31/2021.

*MA residents may select their pharmacy. Otherwise, this free trial will be supplied through XELSOURCE.

CO-PAY CARD TERMS AND CONDITIONS

By using the XELJANZ/XELJANZ XR Co-pay Savings Card (the “Card”), you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions.

  • Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
  • Patient must have private insurance. Offer is not valid for cash paying patients.
  • You will receive a maximum benefit of $15,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year, and may pay as little as $0 per month co-pay. After a maximum of $15,000, you will be responsible for paying the remaining monthly out-of-pocket costs.
  • This Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs.
  • You must deduct the value of this coupon from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
  • You are responsible for reporting use of the Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Card, as may be required. You should not use the Card if your insurer or health plan prohibits use of manufacturer Cards.
  • You must be 18 years of age or older to redeem the Card.
  • The Card is not valid where prohibited by law.
  • The Card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.
  • The Card will be accepted only at participating pharmacies.
  • If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer.
  • The Card is not health insurance.
  • Offer good only in the US and Puerto Rico.
  • The Card is limited to 1 per person during this offering period and is not transferable.
  • The Card may be used once per month for the life of the program.
  • No other purchase is necessary.
  • Data related to your redemption of the Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Card redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke, or amend the program without notice.
  • Card and Program expires 12/31/2019.

If you have questions or are in need of additional support, call 1-844-935-5269 or visit www.XELJANZ.com.

XSAVINGS MOBILE TEXT PROGRAM TERMS & CONDITIONS

User texts "XPROGRAM" to short code 50336.
Text HELP for help, STOP to opt out.
Patients may receive up to 10 messages per month.
Message and data rates may apply.

1. By opting into the XSAVINGS mobile texting program (Program), you consent to receive up to 10 text messages and/or push notifications from Pfizer Inc. Such messages may be marketing or non-marketing messages and may include co-pay related information, fill confirmation, website information, etc. Messages may be delayed or undelivered for various factors. TrialCard, carriers (including, but not limited to, T-Mobile) and any service providers utilized by TrialCard to send messages are not liable for delayed or undelivered messages.

2. To stop receiving text messages, text STOP to 50336. DOING SO WILL ONLY OPT YOU OUT OF THIS PROGRAM; you will remain opted in to any other Pfizer Inc text message program(s) into which you opted separately.

3. To request more information or to obtain help, text HELP to 50336. You can also call customer service at 1-844-935-5269.

4. You represent that you are the account holder for the mobile telephone number(s) that you provide to opt into the Program. You are responsible for notifying Pfizer Inc immediately if you change your mobile telephone number. You may notify Pfizer Inc of a number change by calling 1-844-935-5269.

5. Message and data rates may apply to each text message sent or received in connection with the texting program, as provided in your mobile telephone service rate plan (please contact your mobile telephone carrier for pricing plans). Applicable roaming charges may apply. Charges are both billed and payable to your mobile service provider or deducted from your prepaid account. Pfizer Inc does not impose a separate fee for sending text messages.

6. Data obtained from you in connection with this Program may include your telephone number, your carrier's name, and details of the message (date, time, and content). Pfizer Inc may use this information to contact you and to provide the services you request.

7. For information on data collection and use, please read our full corporate Privacy Policy (https://www.pfizer.com/Privacy), which is incorporated by reference into these Terms.

8. Pfizer Inc will not be liable for any delays in the receipt of any SMS messages, as delivery is subject to effective transmission from your network operator.

9. This Program is available only on these US participating mobile carriers: Verizon Wireless, Sprint, Boost Mobile, T-Mobile, AT&T, Atlantic Tele-Network International (ATNI), Alaska Communications Systems (ACS), ASTAC, Bandwidth.com (includes Republic Wireless), Blue Wireless, Bluegrass Cellular, Breakaway Wireless, Brightlink, C Spire Wireless (aka Cellular South), Carolina West Wireless, CellCom, Cellone Nation, Cellular One of N.E. Arizona, Chariton Valley Cellular, Chat Mobility, Copper Valley Telecom, Cordova Wireless, Cross Wireless, CTC, Custer Telephone, East Kentucky Network (Appalachian Wireless), Enflick, GCI Communications, Google Voice, Illinois Valley Cellular, Inland Cellular, Inteliquent, iWireless, Leaco Rural Telephone Cooperative, Limitless Mobile, Mid-Rivers Communications, MobileNation/SI Wireless, MTA Wireless/Matanuska Kenai, Nemont CDMA, Nemont US UMTS, NewCore Wireless, Nex-Tech Wireless, NNTC Wireless, Northwest Missouri Cellular, Pine Belt Wireless, Pine Cellular, Pioneer Cellular, PTCI, Shelcomm, Silver Star PCS, Snake River PCS, SouthernLINC, SouthernLINC LTE, SRT, STRATA Networks, Standing Rock (SRTI), Thumb Cellular, Triangle Wireless, Union Wireless, U.S. Cellular, United Wireless, Viaero Wireless, Virgin Mobile, West Central Wireless.

10. You agree to indemnify Pfizer Inc and any third parties texting on its behalf in full for all claims, expenses, and damages related to or caused, in whole or in part, by your failure to immediately notify us if you change your telephone number, including but not limited to all claims, expenses, and damages related to or arising under the Telephone Consumer Protection Act.

11. Pfizer Inc may immediately suspend or terminate your participation in the Program if it believes you are in breach of these SMS Terms and Conditions. Your participation in this Program is also subject to termination in the event that your mobile telephone service terminates or lapses. Pfizer Inc reserves the right to modify or discontinue, temporarily or permanently, all or any part of the Program, with or without notice.

12. Pfizer Inc may revise, modify, or amend these SMS Terms and Conditions at any time. Any such revision, modification, or amendment shall take effect when it is posted to Pfizer Inc's website. You agree to review these SMS Terms and Conditions periodically to ensure that you are aware of any changes. Your continued consent to receive text messages will indicate your acceptance of those changes.

 

Important
Safety Update

On Friday July 26, 2019, the US FDA updated the XELJANZ full prescribing information and posted a statement. Pfizer also issued a media statement announcing that the U.S. full prescribing information for XELJANZ® (tofacitinib)/XELJANZ XR has been updated based on the U.S. Food and Drug Administration’s (FDA) review of data from an ongoing post-marketing safety study.

As a result of this review, two additional warnings for Mortality and Thrombosis were included in the Boxed Warning and related Warnings and Precautions section of the prescribing information and in the Most Important Information I Should Know section of the patient Medication Guide for XELJANZ/XELJANZ XR. Additionally, changes to the ulcerative colitis (UC) approved use and recommended dosing were made.

The new Boxed Warning information regarding Mortality discusses the increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The FDA recommended dose in adult patients with rheumatoid arthritis or psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

The new Boxed Warning information regarding Thrombosis includes information on the risk of blood clots. Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

Patients should stop taking XELJANZ/ XELJANZ XR and seek medical attention immediately if they experience any signs or symptoms of a blood clot such as:

Sudden shortness of breath or difficulty breathing

Chest pain

Swelling, pain, or tenderness in leg or arm

Redness or discoloration in leg or arm

Patients should tell their healthcare provider if they have had blood clots in the veins of their legs, arms, or lungs, or clots in arteries in the past.

Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

The FDA approved use of XELJANZ for adults with moderately to severely active ulcerative colitis (UC) now recommends use after medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated. Healthcare providers are advised to use the lowest effective dose to maintain response in patients with UC.

If you have any questions about these updates talk to your healthcare provider.

The updated Important Safety Information and Indications for XELJANZ/XELJANZ XR are included on the following pages for your review.

It is also important to read the patient Medication Guide you receive with your XELJANZ/XELJANZ XR prescriptions, which explains the important things you need to know about the medicine. These include side effects, what the medicine is used for, how to take and store it properly, and other things to watch for when you’re taking the medicine.

Information about Ongoing Post-Marketing Safety Study

This safety study is being conducted in patients 50 years of age and older with rheumatoid arthritis (RA) with at least one heart disease (cardiovascular) risk factor to evaluate the risk of heart-related events and cancer using XELJANZ at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor in combination with methotrexate. The FDA recommended dose in adult patients with rheumatoid arthritis or psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day. XELJANZ/XELJANZ XR 10 mg twice daily is not approved for adult patients with rheumatoid arthritis or psoriatic arthritis.

IMPORTANT SAFETY INFORMATION

XELJANZ/XELJANZ XR may cause serious side effects, including:

Serious infections. XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

Your healthcare provider should test you for TB before starting and during XELJANZ/XELJANZ XR treatment, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ/XELJANZ XR if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of serious infections and shingles.

Before starting XELJANZ/XELJANZ XR, tell your healthcare provider if you:

think you have an infection or have symptoms of an infection, such as fever, sweating, or chills; cough; blood in phlegm; warm, red, or painful skin or sores on your body; burning when you urinate or urinating more often than normal; muscle aches; shortness of breath; weight loss; diarrhea or stomach pain; or feeling very tired

are being treated for an infection

get a lot of infections or have infections that keep coming back

have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections

have TB, or have been in close contact with someone with TB

live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use XELJANZ/XELJANZ XR. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common

have or have had Hepatitis B or C

After starting XELJANZ/XELJANZ XR, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR can make you more likely to get infections or make worse any infection that you have.

Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

Cancer and immune system problems. XELJANZ/XELJANZ XR may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ/XELJANZ XR. People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.

Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT)  and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR.  The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day. Blood clots in the lungs have also happened in patients with ulcerative colitis.  Some people have died from these blood clots.

Stop taking XELJANZ/ XELJANZ XR and tell your healthcare provider right away if you have any signs and symptoms of a blood clot such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ/XELJANZ XR can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.

Serious allergic reactions have happened in patients taking XELJANZ/XELJANZ XR.  If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ/XELJANZ XR and call your healthcare provider right away.

Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, to check for the following side effects:

Changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.

Low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.

Low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.

Your healthcare provider should routinely check certain liver tests.

You should not receive XELJANZ/XELJANZ XR if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ/XELJANZ XR treatment for a period of time if needed because of changes in these blood test results.

You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start XELJANZ/XELJANZ XR, and as needed after that.

What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR?

Before taking XELJANZ/XELJANZ XR, tell your healthcare provider about all of your medical conditions, including if you:

have an infection

have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past

have liver problems

have kidney problems

have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines

have had a reaction to tofacitinib or any of the ingredients in XELJANZ/XELJANZ XR

have recently received or are scheduled to receive a vaccine. People taking XELJANZ/XELJANZ XR should not receive live vaccines but can receive non-live vaccines

plan to become pregnant or are pregnant. XELJANZ/XELJANZ XR may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ/XELJANZ XR. It is not known if XELJANZ/XELJANZ XR will harm an unborn baby.

Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/XELJANZ XR. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ/XELJANZ XR, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll

plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ/XELJANZ XR or breastfeed. You should not do both. After you stop your treatment with XELJANZ/XELJANZ XR do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), golimumab (Simponi®), ustekinumab (Stelara®), secukinumab (Cosentyx®), vedolizumab (Entyvio®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ or XELJANZ XR. Taking XELJANZ or XELJANZ XR with these medicines may increase your risk of infection.

Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Taking XELJANZ/XELJANZ XR

Take XELJANZ 2 times a day with or without food.

Take XELJANZ XR 1 time a day with or without food for rheumatoid or psoriatic arthritis. Do not take XELJANZ XR for ulcerative colitis.

When you take XELJANZ XR, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.

For the treatment of psoriatic arthritis, take XELJANZ/XELJANZ XR in combination with methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.

What are other possible side effects of XELJANZ/XELJANZ XR? XELJANZ/XELJANZ XR may cause serious side effects, including Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ/XELJANZ XR. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR and while you are using XELJANZ/XELJANZ XR. Tell your healthcare provider if you have any of the following symptoms of a possible Hepatitis B or C infection: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis and psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects of XELJANZ in ulcerative colitis patients include nasal congestion, sore throat, and runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

What is XELJANZ/XELJANZ XR? XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated

Adults with active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated

XELJANZ is also used to treat:

Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

It is not known if XELJANZ/XELJANZ XR is safe and effective in children or in people with Hepatitis B or C.

XELJANZ/XELJANZ XR is not recommended for people with severe liver problems.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.